MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 ARISTA AH; AGENT, ABSORBABLE HEMOSTATIC, NON COLLAGEN BASED

Catalog Number	SM0002-USA
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Fever (1858); Sepsis (2067)
Date of Event	11/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the patient with comorbidity underwent tumor resection surgery.As reported, excess blood was removed from the site, arista ah was used, direct pressure was applied and excess arista ah was removed from the surgical site.As reported, the patient showed sign and symptoms of sepsis 24 hours after the procedure, medical intervention was provided and the patient was discharged.
Additional Manufacturer Narrative
Based on the information provided, no conclusion can be made to what if any extent the arista product used caused or contributed to the patient's postoperative course.It was reported that 24 hours post use of the bard/davol arista ah hemostatic powder, patient underwent medical intervention for signs of sepsis.Information provided remains limited to the reported event.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Note, the date of event is provided ((b)(6) 2022) as an estimate based on the information provided.Device not returned.
Additional Manufacturer Narrative
Based on the information provided, no conclusion can be made to what if any extent the arista product used caused or contributed to the patient's postoperative course.It was reported that 24 hours post use of the bard/davol arista ah hemostatic powder, patient underwent medical intervention for signs of sepsis.Information provided remains limited to the reported event.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Note, the date of event is provided (15-nov-2022) as an estimate based on the information provided.Addendum: h11: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to report the additional information provided (lot #), correct annex e code and event description.As reported, patient had signs of fever and sepsis post use of bard/davol arista ah.Review of manufacturing records confirms product was manufactured to specification.Corrected fields: b5 (describe event or problem), h6.Note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
As reported, the patient with comorbidity underwent tumor resection surgery.As reported, excess blood was removed from the site, arista ah was used, direct pressure was applied and excess arista ah was removed from the surgical site.As reported, the patient showed sign and symptoms of fever and sepsis 24 hours after the procedure, medical intervention was provided and the patient was discharged.

• Brand Name: ARISTA AH
• Common Device Name: AGENT, ABSORBABLE HEMOSTATIC, NON COLLAGEN BASED
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): DAVOL INC. -1223089; 160 new boston st.; woburn MA 01801
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 16016338
• Report Number: 1213643-2022-00808
• Device Sequence Number: 14857875
• Product Code: LMG
• UDI-Device Identifier: 00801741044106
• UDI-Public: (01)00801741044106
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: P050038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/28/2023
• Device Catalogue Number: SM0002-USA
• Device Lot Number: 6099501
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/02/2022
• Supplement Date Received by Manufacturer: 12/14/2022
• Initial Report FDA Received Date: 12/20/2022
• Supplement Report FDA Received Date: 01/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Unknown